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EC number: 932-165-8
CAS number: -
There are no
studies available in which the toxicokinetic behaviour of any member of
the Vinasses chemical category has been investigated.
assessment of toxicokinetics of Vinasses is conducted on a qualitative
basis taking into account the available information on substance
definition as well as physicochemical and toxicological characteristics
according to Guidance on information requirements and chemical safety
assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2008).
All members of
the Vinasses category share a common origin and production process.
Vinasses are by-products of a fermentation process, at the end of which
the target fermentation product(s) and, if applicable, the
micro-organism biomass are removed from the fermentation broth by
appropriate methods. Vinasses are contained in the resulting liquid,
which is usually concentrated by physical means.
result from a controlled fermentation processes involving complex
biological raw materials and different micro-organisms, they are
regarded as typical substances of unknown or variable composition of
biological origin (UVCB). Based on dry matter content, Vinasses are
mainly composed of biological macromolecules (primarily proteins, but
also sugars and lipids) and ash residue which includes mineral salts of
both biological (from the raw materials) and non-biological origin
(added during the production process), particularly potassium and sodium
distribution, metabolism and excretion of biomolecules (proteins,
sugars, lipids) have been extensively studied, are well-understood and
adequately described in the relevant literature (Despopoulos, A and
Silbernagl, S., 2001; Elmadfa, I. and Leitzmann, C., 2004; Löffler, G et
al., 2007; Rehner, G. and Daniel, H., 2002; Karlson, P and Doenecke, D.,
2005). It is outside the scope – and not the aim – of this assessment to
reproduce this information in the present context. Where applicable,
supporting information on biomolecules is shortly discussed along with
substance specific data. The same approach applies to relevant mineral
salts in Vinasses, particularly potassium and sodium sulfates.
As expected for
substances of biological origin, Vinasses contain both water soluble and
insoluble material. For Vinasses, residue of fermentation containing
biomass of Corynebacterium glutamicum, around 30 to 40 % (w/w) of
dry matter is composed of material with a relatively high water
solubility (Oudhoff, 2010).
substances will readily dissolve into the gastrointestinal fluids, and
compounds of low molecular weight (less than 200) may pass through
aqueous pores or be carried through the epithelial barrier of the
gastrointestinal tract by the bulk passage of water. Lipophilic
compounds may be taken up by micellar solubilisation.
information on the absorption potential of Vinasses can be obtained from
the available oral toxicity data. Vinasses have been tested in acute
oral toxicity studies, resulting in LD50 values greater than 5000 mg/kg
bw without signs of toxicity. The very low toxic potential of Vinasses
via the oral route has been confirmed in subacute and subchronic studies
in rats, in which systemic effects were observed only at high dose
levels: In an oral prenatal developmental toxicity study in rats, the
LOAEL for maternal toxicity was 8700 mg/kg bw/day based on decreased
body weight and food consumption, which both can be attributed to the
high ammonium content of the test substance (Wolterbeek, 2003); in a
subchronic oral toxicity study in rats, treatment-related effects were
observed at the highest dose level tested (8000 mg/kg bw/day in males
and 9600 mg/kg bw/day in females) consisting of a decrease in plasma
chloride in females and an increase in relative liver weight in animals
of both sexes. These changes were, however, minor and not associated
with any histopathological changes (Appel, 2003).
are used as feed material due to their high protein content. The effects
of partially or entirely replacing soybean meal by Vinasses as protein
source in feed has been investigated in a number of studies in different
effects on growth and slaughter performance and no indications for
toxicologically relevant changes were reported after feeding Vinasses,
residue of fermentation containing biomass of bakers yeast (Saccharomyces
cerevisiae) to young female goats at 2526 and 4995 mg/kg bw/day for
6 months (Ringdorfer, 2009); to dairy cows at 640 and 1296 mg/kg bw/day
for 12 weeks (Urdl and Schauer, 2009); to bulls at 2135 mg/kg bw/day for
356 days (Leitgeb, 2010); to pigs at 10428 mg/kg bw/day for 55 days and
at 5245 mg/kg bw/day for further 45 days (Windisch and Schedle, 2010).
In chicks fed Vinasses
at 8, 16 and 24 % in diet for 36 days, a significant decrease in growth
and slaughter performance was observed at the highest concentration with
slight evidence of dose-dependency (Windisch and Leitgeb, 2009). The
corresponding Vinasses mean dose levels over the study period were 6438,
13197 and 20780 mg/kg bw/day. The decrease in daily body weight gain was
correlated with a decrease in daily feed intake. The absolute weight of
abdominal fat, heart, liver stomach and individual body parts determined
at the end of the study was also significantly decreased at the highest
dose level. However, except for breast, the corresponding relative
weights were not reduced and even a slight dose-dependent increase was
the results of these feeding studies indicate that at least the protein
fraction of Vinasses is digested, absorbed and metabolised as
effectively as soybean protein without toxicologically relevant effects
to livestock species.
consistent with a study in bulls and pigs, in which the digestibility of Vinasses
components was investigated (Stemme et al., 2005). In bulls fed Vinasses
at 14% in diet, digestibilities of Vinasses components were: organic
matter 73.5%, crude protein 72.6% and N-free extract 52.3%. No effects
on faeces quality were observed. In pigs fed 16% Vinasses, the
digestibility of organic matter was 72.3%, of crude protein 71.8% and of
N-free extract 74.6%. Digestibility values of organic matter and crude
protein were reduced (61.6 and 57.7%, respectively) in pigs fed Vinasses
at 43%. The authors stated that this effect might have been due to a
reduced retention time of the chyme resulting from an osmotically driven
diarrhoea related to an unexpectedly high sulfate content in the Vinasses
used. The authors concluded that the use of Vinasses in bulls and pigs
in small proportions is reasonable based on the organic matter
digestibility of > 70%.
information on constituents:
and carbohydrates are constituents of normal diet and essential for the
physiological function of the organism. In general, these biomolecules
are readily absorbed via the gastrointestinal tract after enzymatic
degradation by endogenous proteases, lipases and amylases. However, Vinasses
may also contain an enriched fraction of non-starch polysaccharides
(NSP), which are in general poorly digestible (Windisch and Schedle,
essential for the maintenance of the total body fluid homeostasis and
the blood pressure. It is also a key ion for the osmotic balance between
the intra- and extracellular fluid, resulting in the electrochemical
gradient, amongst others, essential for neuronal function. Due to these
roles, the body sodium level is regulated by hormones and ion-pumps on
the cellular level. The absorption of sodium is very fast and almost
potassium is also a key element in regulation of osmotic balance between
cells and the interstitial fluid as well as in neuronal function. The
cellular content is regulated by ion pumps, which pump 3 sodium ions out
of the cell and 2 potassium ions into the cell, thus creating an
electrochemical gradient over the cell membrane. The absorption of
potassium is achieved by active transport and is fast and almost
Sulfate is a
constituent of the blood and as well as a metabolite of
sulfur-containing amino acids. The absorption of sulfate depends on the
amount ingested. Absorption of small amounts of sulfate from the
gastro-intestinal tract occurs rapidly and almost completely.
based on the available information on composition, physicochemical
parameters and toxicological characteristics, a high level of absorption
is expected for Vinasses via the oral route.
substance class and physicochemical properties of the main components,
the absorption of Vinasses via the lung is expected to be lower than –
and in the worst case equal to – the absorption via the gastrointestinal
tract. As stated above, biomolecules in Vinasses are readily absorbed
via the oral route and absorption is largely facilitated by enzymatic
activity. This activity is, however, expected to be low or even lacking
in the mucus lining fluid of the respiratory tract. Water-soluble salts
might be absorbed through water pores or be retained in the mucus and
transported out of the respiratory tract. Insoluble material (particles)
of inhalable size (MMAD < 100 µm) will likely be cleared from the lung
with the mucus and swallowed.
state/appearance of Vinasses largely depends on the water content. As
described at the beginning of this section, the primary produced Vinasses
in liquid form resulting from the fermentation process is usually
concentrated by physical means. Depending on the degree of
concentration/drying and compression, this results in Vinasses as
viscous liquid, slurry or paste and finally dry pelleted powder.
liquid form are used as fertilizers and applied on fields by spreading
activities. Due to the high viscosity of the liquid, the formation of,
and consequently the exposure to, aerosols or droplets of respirable
size is not expected to occur and therefore considered not relevant for
data on the particle size distribution of Vinasses as dry pelleted
material indicate that most of the particles are larger than 100 µm, and
thus not inhalable (Agroethanol; Brekelmans, 2010). Therefore, exposure
to respirable particles (MMAD < 5 µm) is unlikely and considered not
significant for humans.
is not a relevant route of exposure for Vinasses.
of Vinasses as whole substance is considered to be low to very low based
on the following considerations:
both as viscous liquids and dry material. Liquids and substances in
solution are more readily absorbed than dry particulates. Dry
particulates need to dissolve into the surface moisture of the skin
before absorption can begin.
composed of both relatively high water soluble and insoluble compounds.
The water soluble components (particularly mineral salts) may be too
hydrophilic to cross the lipid rich environment of the stratum corneum.
Dermal uptake for these substances will be low. The less soluble
components may be able to penetrate the stratum corneum, provided that
they are lipophilic enough (e. g. lipids). However, partition from the
stratum corneum into the epidermis will be limited again by the low
animal data indicate that Vinasses are not skin irritating. Based on the
weight of evidence, the available animal and human data on skin
sensitisation is inconclusive.
data on the acute dermal toxicity of Vinasses in rats indicated the
occurrence of slight clinical signs on days 1 and/or 2 of the study.
These effects are, however, considered to be due to animal handling
rather than substance-related. This is supported by the lack of signs of
intoxication reported in acute oral toxicity studies.
considerations on constituents:
mainly composed of proteins and other biomolecules (carbohydrates,
lipids). The dermal absorption of these compounds is considered to be
much lower than the absorption via the oral route, as the latter is
facilitated by and dependent on enzymatic activity in the
based on the available information on composition, physicochemical
parameters and toxicological characteristics, a dermal absorption
potential of individual components of Vinasses cannot be completely
excluded but is expected to be low to very low when considering the
substance as a whole and compared to the oral route.
components of Vinasses (dietary biomolecules as well as water soluble
mineral salts, in particular potassium and sodium sulfate) are expected
to be systemically bioavailable.
Vinasses as a
whole are not expected to bioaccumulate. Orally absorbed dietary
biomolecules in Vinasses are expected to undergo metabolic
transformation according to their respective substance class (proteins,
carbohydrates, lipids) and used as energy source or become an integral
part of the organism. Thus, organic matter in Vinasses may accumulate in
the body as structural elements of e. g. muscle or adipose tissue. This,
however, is a desired consequence of the intentional use of Vinasses as
mineral salts from Vinasses (containing potassium, sodium, sulfur and to
a lesser extent phosphorus) are also expected to be retained in the
organism as essential elements necessary for normal physiological
functions. Except for elements becoming part of the bone tissue
(phosphorus), most salts are, however, not expected to remain in the
organism for longer periods of time, as they are continuously and
effectively eliminated via the urine.
As stated at the
beginning of this section, it is outside the scope and not the aim of
this assessment to reproduce the extensively studied and
well-established metabolic pathways of dietary biomolecules. Reference
is made to the relevant literature (Despopoulos, A and Silbernagl, S.,
2001; Elmadfa, and Leitzmann, C., 2004; Löffler, G et al., 2007; Rehner,
G. and Daniel, H., 2002; Karlson, P and Doenecke, D., 2005).
feeding studies described above support the notion that the orally
absorbed fraction of organic matter (especially proteins) in Vinasses is
metabolised in accordance with its substance class.
mineral salts in Vinasses are not prone to undergo metabolic
non-digestible fraction of Vinasses will be excreted in the faeces.
Due to the
variety of metabolic pathways which the orally absorbed organic matter
from Vinasses may undergo, it is not possible to identify the most
likely route of excretion. All major routes including urine, exhaled
air, bile, breast milk, saliva/sweat and hair/nails are possible.
sodium is very low since it is reabsorbed in the glomeruli of the
kidney. Nonetheless, the main elimination route for sodium is via urine.
For potassium, excretion occurs mainly via the kidney and only partly by
excretion, it was found that 30 - 44% was excreted in the 24-h urine of
volunteers after oral administration of magnesium or sodium sulphate
(5.4 g sulfate). At high doses that exceed the intestinal absorption
potential, sulfate is excreted in faeces with possible cathartic
effects. The sulfate levels are regulated by the kidney through a
resorption mechanism, so that excess sulfate originated from the amino
acid metabolisms is usually eliminated by renal excretion. The daily
sulfate excretion is reported to be 0.20 to 0.25 mmol/kg bw/day and
being higher in children (Health Canada, 1987 and 1994).
Canada Health, November 1987 (updated
September 1994), Sulfate. Available: http://www.hc-sc.gc.ca
Cocchetto, D.M. and Levy, G. (1981).
Absorption of orally administered sodium sulphate in humans. J. Pharm.
Despopoulos, A and Silbernagl, S.
(2001). dtv-Atlas Physiologie.Die Funktionen des menschlichen
Körpers. 14th ed. Deutscher Taschenbuch Verlag, München.
Elmadfa, I. and Leitzmann, C. (2004).
Ernährung des Menschen. 4th ed. Eugen Ulmer, Stuttgart.
Karlson, P and Doenecke, D. (2005). Karlsons
Biochemie und Pathobiochemie : [Falttafel mit Stoffwechselübersicht].
14th ed. Thieme, Stuttgart.
Löffler, G et al. (2007). Biochemie und
Pathobiochemie. 5th ed. Springer, Berlin Heidelberg New York.
Potts, W.T.W.; Parry, G. (1964).Osmotic
and ionic regulation in animals. Pergamon Press.
Rehner, G. and Daniel, H. (2002). Biochemie
der Ernährung. 2nd ed.Spektrum.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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